BRUSSELS, Belgium -- Legislative streamlining for clinical trials in Europe -- with special provisions for biotechnology medicines -- won the backing of the European Parliament at its monthly plenary session in Strasbourg, France, on Nov. 17. Euro-MPs enthusiastically supported the European Union (EU) draft directive aimed at harmonizing clinical trial authorization procedures across the 15 member states, particularly to help speed the start-up of multicenter trials. Overall, the new measure is likely to cut bureaucratic delays. But for some biotechnology products, the parliament recognized that ethics committees may need extra time for reflection before granting approval.

One of the key aims is to prevent applications from getting bogged down within the ethics committees that are crucial to the system. These committees will be allowed to send only a single request for information supplementary to that already supplied when a trial sponsor submits a protocol, and committees are to be allowed only a further 15 days to review these new data.

"No additional extension shall be permissible beyond that limit," insisted the parliament, "except in the case of trials involving gene therapy and xenotransplantation."

Overall, the parliament went further in its streamlining than the European Commission proposal of late last year. "The pharmaceutical industry in Europe is highly innovative and helps to protect public health by developing new medicines for diseases for which there is no specific or sufficiently effective treatment," the parliament said. "Innovation consequently depends on clinical research and should not be hampered by needless red tape."

Among some 30 changes the parliament wants to see in the current draft text is one regarding how much national flexibility EU member states should have in controlling clinical trials. The Euro-MPs argued the measure must provide a single regulatory framework on which rapid drug development increasingly depends. Basing itself on the report from Italian independent Euro-MP Amedeo Amadeo for the parliament's committee on environment, public health and consumer protection, the parliament insisted on an end to the current diversity of systems, under which most member states require only notification of the national regulatory authorities before a trial starts, while a few require full-scale authorization. The commission is proposing a compromise to allow continuation of choice for member states, in a bid to escape political pressure from member states reluctant to abandon their own systems. But the parliament accepted the argument that notification alone, by all states, would make for a closer, Europe-wide harmonization of the system.

Agreement Reached On Funding Program

The parliament also added a number of safeguards. It required that a doctor supervise all trials. It intensified the reporting requirements in the event that unexpected adverse effects are observed during a trial. It expanded the requirements for patients to give their informed consent, with a new definition of the phrase inserted. "Informed consent" is to mean: "The taking by the subject of a decision to participate voluntarily in a trial after having been informed of all the significant aspects by means of a written document which must be dated and signed." And the parliament boosted the data-protection provisions in the proposal -- to protect patients' privacy and limit dissemination of commercially sensitive information that could undermine an innovator's competitive position.

In other EU news, the union at last reached agreement on its 1998-2002 scientific research and development program. The move is expected to unlock $15 billion of EU funding to assist private and academic research across all fields, with a significant allocation for life sciences, including medicine and biotechnology (although details are to be decided before the end of the year). The first opportunities to apply for grant funding will start to emerge early in 1999. But one of the specific conditions to the EU deal -- which was a hard-fought compromise between the European Parliament and the research ministers of the 15 EU member states -- is that "any activities involving human cloning will be excluded from the program." *

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